North Haven Imports & Compliance Group LLC provides FDA U.S. Agent and Official Correspondent support services for foreign manufacturers of FDA-regulated products, including food, drugs, and medical devices. We serve as a U.S.-based point of contact to support regulatory communication and coordination with the U.S. Food and Drug Administration.

Our services are designed to support regulatory communication readiness, documentation coordination, and compliance support for foreign firms required to designate a U.S. Agent under applicable FDA regulations. We assist clients in maintaining organized, accurate records and ensuring FDA communications are properly received and addressed.

What We Support

Our FDA U.S. Agent and Official Correspondent services may include:

• Serving as the designated FDA U.S. Agent for foreign manufacturers

• Acting as Official Correspondent for FDA communications, as applicable

• Receiving and coordinating FDA communications, inquiries, and notifications

• Supporting updates to FDA registrations and listings, when appropriate

• Coordination support during FDA inspections, audits, or compliance inquiries

• Maintaining availability as a U.S.-based regulatory contact

Our Role

North Haven serves as a regulatory communication partner, helping foreign manufacturers maintain a reliable U.S. presence for FDA correspondence. We support timely communication, documentation coordination, and regulatory readiness while helping clients understand and respond appropriately to FDA inquiries.

Industries Served

• Foreign medical device manufacturers

• Foreign food and beverage producers

• Drug and ingredient manufacturers

• FDA-regulated product companies entering the U.S. market

Commitment to Compliance

Our FDA U.S. Agent and Official Correspondent services are advisory and administrative in nature and are intended to support compliance with applicable FDA requirements. We do not provide legal representation or act as a regulatory authority.